Prevention of Childhood Anxiety Disorders in Offspring of Anxious Parents

NCT ID: NCT04722731

Last Updated: 2023-10-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 215 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-15
• Study Completion Date: 2025-07-01

Brief Summary

This study aims to expand the evidence of prevention of anxiety disorders in children. Children of anxious parents are at increased risk of developing anxiety disorders. Twin studies support a direct environmental transmission of anxiety between parent and child, and a main mechanism is suggested to be the parenting style of anxious parents, characterised by criticism and rejection, overprotection and modelling of anxiety.

This study will take a novel approach to prevent childhood anxiety disorders by evaluating the Confident Parents - Brave Children (CPBC) program, a parent program targeting anxious parents, in a randomised controlled trial (RCT).

Detailed Description

RESEARCH QUESTIONS

• Is the CPBC-program effective in preventing childhood anxiety disorders within a period of 12 and 36 months respectively, compared to a self-help parenting book?
• Is the CPBC-program effective in preventing childhood anxiety symptoms within a period of 12 and 36 months respectively, compared to a self-help parenting book?
• Is the effect moderated by severity of parental anxiety, child anxiety symptoms at baseline, or gender or age of the child?
• Is the study effective in increasing parental self efficacy?
• Is the effect of CPBC-program mediated by changes in parental criticism and rejection, overprotection, parental modelling of anxiety or parental accommodation?
• Is the CPBC-program cost-effective?

DESIGN The first study is a full scale parallel randomised controlled trial (allocation ratio 1:1). This study will include follow-up assessments after 12 and 36 months and will evaluate the relative efficacy of the CPBC-program versus an active control group (self-help book). The second part includes a mediation analysis and the third part is a within trial economic evaluation comparing the outcomes and costs between the CPBC-program and control using two types of analyses (cost-utility analysis and cost-consequence analysis).

POWER To have an 80% power to detect a significant (p ≤ 0.05) small to moderate difference (standardised mean difference = 0.4) the investigators will need to recruit 194 children. Given an anticipated attrition of 10%, the investigators will aim at including a total of 216 children. Participants will be recruited through advertisements. The participants will be randomly allocated to either (1) CPBC-program or (2) reading a self-help book.

Conditions

Anxiety Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Confident Parents - Brave Children

The Confident Parents - Brave Children (CPBT) is a group parent training targeted to anxious parents, delivered by a psychologist via video conference (the Zoom software solution).

The CPBT will comprise six 120-minutes digital sessions. One month after the last group session, all parents will be offered to have an individual booster session with a psychologist over Zoom.

Group Type: EXPERIMENTAL

Confident Parents - Brave Children (CPBT)

Intervention Type: BEHAVIORAL

Session 1: Psychoeducation.

Session 2: How to decrease criticism and rejection. Skills that provide a warm parenting style and acceptance of the child: validation and child directed play/activities.

Session 3: Strategies to increase the autonomy of the child. The parents will learn how to use a stepladder approach to decrease overprotective behaviours.

Session 4: How to decrease modelling of anxious behaviours and how to be a brave role model.

Session 5: How to recognise and respond when your child is anxious. How to help your child approach new or scary things by using a stepladder approach.

Session 6: Review of the principles and skills learned during the program. The group members will make a plan for how to continue the work on their own.

Self-help book

In the control group, participants will receive a parenting book, titled "What all parents ought to know". This is a self-help book for parents, partly based on the scientifically evaluated parent program "All Children in Focus".

Group Type: ACTIVE_COMPARATOR

Self-help book "What all parents ought to know"

Intervention Type: BEHAVIORAL

Participants in the control group will receive a self-help parenting book containing general research-based parenting strategies. They will be instructed to read the book within the 10 weeks from baseline to post.

Interventions

Confident Parents - Brave Children (CPBT)

Session 1: Psychoeducation.

Session 2: How to decrease criticism and rejection. Skills that provide a warm parenting style and acceptance of the child: validation and child directed play/activities.

Session 3: Strategies to increase the autonomy of the child. The parents will learn how to use a stepladder approach to decrease overprotective behaviours.

Session 4: How to decrease modelling of anxious behaviours and how to be a brave role model.

Session 5: How to recognise and respond when your child is anxious. How to help your child approach new or scary things by using a stepladder approach.

Session 6: Review of the principles and skills learned during the program. The group members will make a plan for how to continue the work on their own.

Intervention Type: BEHAVIORAL

Self-help book "What all parents ought to know"

Participants in the control group will receive a self-help parenting book containing general research-based parenting strategies. They will be instructed to read the book within the 10 weeks from baseline to post.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. The parent suffers from exaggerated worry or anxiety

2. The parent speaks and reads Swedish

3. The child is 5-9 years old

4. The child receives a clinicians assigned clinical severity rating (CSR) of 1 to 3 on anxiety disorders in ADIS-C (subclinical symptoms of anxiety)

Exclusion Criteria

1. Current or recent parental alcohol or substance abuse

2. The parent suffer from severe psychiatric conditions (e.g.current or recent psychotic or manic/hypomanic symptoms, severe depression or increased risk of suicide)

3. Social conditions that would obstruct from participation (e.g.ongoing custody dispute, domestic violence, ongoing investigation of child neglect through social services)

4. The child suffers from/is currently in treatment for an anxiety disorder or depression

5. The child is currently undergoing a neuropsychological evaluation

6. The child has no symptoms of anxiety at all (the child receives a clinicians assigned CSR of 0 on all anxiety disorders in the ADIS-C interview )

7. The child meet criteria for an anxiety disorder (the child receives a clinicians assigned CSR of 4 or above on any anxiety disorder in ADIS-C interview )

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Johan Åhlén

Project coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Karolinska Institutet

Solna, , Sweden

Countries

Sweden

References

Elfstrom S, Rosengren A, Andersson R, Engelbrektsson J, Isaksson A, Meregalli M, van Leuven L, Lalouni M, Ost LG, Ghaderi A, Ahlen J. Evaluating a program to prevent anxiety in children of anxious parents: a randomized controlled trial. J Child Psychol Psychiatry. 2025 Sep;66(9):1345-1356. doi: 10.1111/jcpp.14151. Epub 2025 Mar 12.

Reference Type: DERIVED

PMID: 40077809 (View on PubMed)

Other Identifiers

JASE01

Identifier Type: -

Identifier Source: org_study_id